Apparatus and methods for injecting high viscosity dermal fillers

ABSTRACT

A method includes inserting a distal end portion of a needle of a medical injector into a skin of a body. An energy source operatively coupled to the medical injector is actuated such that a dermal filler is conveyed from the medical injector into the skin through the distal end portion of the needle. The distal end portion of the needle is moved within the skin during the actuating.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.12/114,194, entitled “Apparatus and Methods for Injecting High ViscosityDermal Fillers,” filed May 2, 2008, which is a continuation-in-part ofInternational Patent Application No. PCT/US2007/023226, entitled“Compositions, Devices and Methods for Modifying Soft Tissue,” filedNov. 1, 2007, which claims priority to U.S. Provisional Application Ser.No. 60/856,430, entitled “Soft Tissue Modification,” filed Nov. 3, 2006,U.S. Provisional Application Ser. No. 60/857,546, entitled “Soft TissueModification,” filed Nov. 8, 2006, and U.S. Provisional Application Ser.No. 60/857,755, entitled “Injection Device,” filed Nov. 8, 2006, each ofwhich is incorporated herein by reference in its entirety.

U.S. application Ser. No. 12/114,194 also claims priority to U.S.Provisional Application Ser. No. 60/964,066, entitled “ControlledInjection Device,” filed Aug. 8, 2007, U.S. Provisional Application Ser.No. 60/993,541, entitled “Controlled Injection Device,” filed Sep. 12,2007, and U.S. Provisional Application Ser. No. 61/016,223, entitled“Self-Contained Pressurized Injection Device,” filed Dec. 21, 2007, eachof which is incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to medical devices and methods, and moreparticularly to medical devices and methods for injecting high viscositydermal fillers into a body.

High viscosity medicaments, such as dermal fillers, can be injected intothe body to augment soft tissue portions within the body. For example,high viscosity compositions can be injected adjacent the urinarysphincter muscle to increase the volume of the tissue within the urinarytract to treat urinary incontinence. High viscosity compositions canalso be injected into the skin to change the contour of and/or increasethe volume of the skin. For example, known high viscosity compositionscan be injected within facial skin to remove wrinkles, treat scars orthe like.

Some known procedures for injecting high viscosity dermal fillersinclude injecting the dermal filler using a standard syringe. In suchprocedures, the force and/or pressure required to convey the dermalfiller from the syringe body through the needle can be generatedmanually by having the user manually depress a plunger into the syringebody. The force generated by manually depressing a plunger, however, canbe sporadic, thus resulting in undesirable fluctuations in the flow ofthe dermal filler through the needle, which can result in the userinjecting more or less dermal filler at a particular location within thebody than is desired. Generating the injection force and/or pressuremanually can also result in inconsistent results between differentusers. Moreover, in certain situations, the force generated by manuallydepressing a plunger can be insufficient to provide the desired flowrate of dermal filler. Additionally, because the total volume of dermalfiller injected is a function of the length of travel of the plunger, itcan be difficult to deliver a sufficient volume of dermal filler wheninjecting the dermal filler manually using a standard syringe. Moreover,generating the injection force and/or pressure manually can result inuser fatigue and/or chronic health problems for the user, such as, forexample arthritis.

Thus, a need exists for improved apparatus and methods for injectinghigh viscosity dermal fillers into a body.

SUMMARY

Medical injectors and methods of injecting high viscosity dermal fillersare described herein. In some embodiments, a method includes inserting adistal end portion of a needle of a medical injector into a skin of abody. An energy source operatively coupled to the medical injector isactuated such that a dermal filler is conveyed from the medical injectorinto the skin through the distal end portion of the needle. The distalend portion of the needle is moved within the skin during the actuating.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flow chart illustrating a method of assembling a medicalinjector according to an embodiment.

FIGS. 2-4 are schematic illustration showing a portion of a body Bcontaining a dermal filler in a first configuration, a secondconfiguration and a third configuration, respectively, according to themethod illustrated in FIG. 1.

FIG. 5 is schematic illustration showing a portion of a body Bcontaining a dermal filler injected therein by a method according to anembodiment.

FIGS. 6 and 7 are schematic illustrations of a medical device accordingto an embodiment, in a first configuration and a second configuration,respectively.

FIG. 8 is a side view of a portion of a system for injecting dermalfillers according to an embodiment.

FIGS. 9 and 10 are perspective views of a portion of the system forinjecting dermal fillers shown in FIG. 8.

FIG. 11 is a side view of a portion of a system for injecting dermalfillers according to an embodiment.

FIG. 12 is a side view of a portion of a system for injecting dermalfillers including a pressure amplifier according to an embodiment.

FIG. 13 is a perspective view of a portion of a system for injectingdermal fillers according to an embodiment.

FIG. 14 is a perspective view of a system for injecting dermal fillersincluding a self-contained source of pressurized fluid according to anembodiment.

FIG. 15 is a perspective view of a portion of the system for injectingdermal fillers shown in FIG. 14.

FIG. 16 is an exploded view of the portion of the system for injectingdermal fillers shown in FIG. 15.

FIG. 17 is a cross-sectional view of the portion of the system forinjecting dermal fillers shown in FIG. 15.

DETAILED DESCRIPTION

In some embodiments, a method includes inserting a distal end portion ofa needle of a medical injector into a skin of a body. The skin caninclude, for example, facial skin. An energy source operatively coupledto the medical injector is actuated such that a dermal filler isconveyed from the medical injector into the skin through the distal endportion of the needle. The energy source can include, for example, apressurized fluid configured to move a piston within the medicalinjector. The distal end portion of the needle is moved within the skinduring the actuating. In some embodiments, a non-manually-poweredmachine operatively coupled to the medical injector is actuated suchthat a dermal filler is conveyed from the medical injector into the skinthrough the distal end portion of the needle. Optionally, the method caninclude regulating a flow rate of the dermal filler through the distalend portion of the needle during the actuating.

As used herein, the words “proximal” and “distal” refer to directioncloser to and away from, respectively, an operator (e.g., surgeon,physician, nurse, technician, etc.) of the medical device. Thus, forexample, the end of the medicament delivery device contacting thepatient's body would be the distal end of the medicament deliverydevice, while the end opposite the distal end would be the proximal endof the medicament delivery device.

As used herein, the words “non-manual” or “non-manually” are used todescribe an operation and/or an apparatus in which a source of energyand/or a force for carrying out the operation and/or a function of theapparatus is not directly produced by a human. For example, an apparatusfor non-manually injecting a dermal filler can include any apparatus inwhich the force to inject the dermal filler is not directly produced bya human. Examples of a non-manual injection apparatus include anapparatus having a compressed gas source to provide the injection force,an apparatus having a spring to provide the injection force, and anapparatus having an electric motor to provide the injection force. Anapparatus for non-manually injecting a dermal filler, however, caninclude a manual actuator (e.g., an on/off switch, a push button, a footpedal or the like) to initiate the non-manual injection.

FIG. 1 is a flow chart illustrating a method 10 of injecting a dermalfiller according to an embodiment. FIGS. 2-4 are schematic illustrationsshowing a portion of a body B containing a dermal filler 118 injectedtherein according to the method 10, in a first configuration, a secondconfiguration and a third configuration, respectively. As shown in FIG.1, the illustrated method includes inserting a distal end portion of aneedle of a medical injector into a skin of a body, at 12. The skin canbe disposed at any location of the body, such as for example, facialskin. Referring to FIG. 2, the distal end portion 122 of the needle 120is inserted into the skin SK in a distal direction as shown by the arrowAA. The needle 120 is inserted into the skin SK at an angle Θ relativeto the surface of the skin SK and at depth d within the body B. Theneedle 120 can be inserted into the skin SK at any suitable angle Θ andat any suitable depth d for achieving the desired result. In someembodiments, for example, the needle 120 is inserted into the skin SK atan angle Θ of between 5 and 35 degrees. In other embodiments, the needle120 is inserted into the skin SK at an angle Θ of approximately 20degrees. In some embodiments, for example, the needle 120 is insertedinto the skin SK at a depth d of between 1.5 and 6 millimeters. In otherembodiments, the needle 120 is inserted into the skin SK at a depth d ofbetween approximately 1.5 and 2 millimeters.

Although the distal end portion 122 of the needle 120 is shown as beinginserted into the subcutaneous tissue S of the skin SK, in someembodiments, the distal end portion 122 of the needle 120 can beinserted into the epidermis E and/or the dermis D of the skin SK. Inother embodiments, the distal end portion 122 of the needle 120 can beinserted below the subcutaneous tissue S. In yet other embodiments, thedistal end portion 122 of the needle 120 can be inserted through theskin SK into another portion of the body B, such as for example aurinary sphincter (not shown in FIGS. 2-5).

Returning to the flow chart shown in FIG. 1, an energy sourceoperatively coupled to the medical injector is actuated such that adermal filler is conveyed from the medical injector into the skinthrough the distal end portion of the needle, at 14. As shown in FIG. 3,the energy source 150 is actuated via an actuator 153. The energy source150 can include any suitable form of energy that can act upon themedical injector 100 to convey the dermal filler 118 from the medicalinjector 100 through the distal end portion 122 of the needle 120. Forexample, in some embodiments, the energy source 150 can include apressurized gas that exerts a force on a portion of the medical injector100. When the energy source 150 is actuated by the actuator 153, thedermal filler 118 is conveyed from the medical injector 100 through thedistal end portion 122 of the needle 120. In this manner, the dermalfiller 118 can be injected into the body B non-manually. Said anotherway, the dermal filler 118 can be injected into the body B without theuser producing the energy necessary for the injection.

Returning to the flow chart shown in FIG. 1, the distal end portion ofthe needle is moved within the skin when the energy source is beingactuated, at 16. In this manner, the user can vary the location of thedistal end portion of the needle within the skin when the dermal filleris being injected into the body B. As shown in FIG. 4, the distal endportion 122 of the needle 120 is moved in a proximal direction, as shownby the arrow BB, when the energy source 150 is being actuated. In thismanner, the user can inject a substantially continuous bead of dermalfiller 118 along a desired passageway (e.g., a wrinkle) within the skinSK. More particularly, the distal end portion 122 of the needle 120 ismoved in a direction substantially opposite the direction of flow of thedermal filler 118 from the distal end portion 122 of the needle 120(shown by the arrow CC in FIG. 4).

Because the dermal filler 118 is conveyed from the distal end portion122 of the needle 120 non-manually, the user is not burdened withproducing a force in the distal direction (to inject the dermal filler118) while simultaneously moving the distal end portion 122 of theneedle 120 in the proximal direction. In this manner, the operation ofproducing a force to inject the dermal filler 118 is independent fromthe operation of moving the distal end portion 122 of the needle 120.Similarly stated, the operation of producing a force to inject thedermal filler 118 is decoupled from (i.e., is separate and distinctfrom) the operation of moving the distal end portion 122 of the needle120. This arrangement can result in a repeatable, continuous and/orcontrolled movement of the distal end portion 122 of the needle 120and/or injection of the dermal filler 118. In contrast, some knownmedical injectors require the user to use the same hand to produce aforce in a distal direction along a longitudinal axis of the medicalinjector to inject a dermal filler and move the needle along thelongitudinal axis, for example, in an opposite (i.e., proximal)direction. In such instances, the injection of the dermal filler can beirregular, uncontrolled and/or discontinuous. Moreover, the disadvantageof such manual injection procedures can be exacerbated when injectinghigh viscosity dermal fillers, because, as described herein, the forceto inject such dermal fillers can be in excess of approximately 4.5 N(10 lbf). For example, when injecting high viscosity dermal fillersusing known medical injectors, it can be difficult for the user tomaintain the force necessary to inject the dermal filler at the desiredflow rate throughout the injection event. Thus, when injecting highviscosity dermal fillers using known medical injectors, the resultingbead of dermal filler can have undesirable spatial variability in itssize and/or volume.

Although the distal end portion 122 of the needle 120 is shown anddescribed above as being moved in the proximal direction when the energysource 150 is being actuated, in other embodiments, the distal endportion 122 can be moved in any manner. For example, in some embodimentsthe distal end portion 122 of the needle 120 can be moved in a distaldirection (i.e., in substantially the same direction as the flow of thedermal filler 118 from the distal end portion 122 of the needle 120). Inother embodiments, the distal end portion 122 of the needle 120 can bemoved in a direction not parallel to a longitudinal axis of the needle120. In yet other embodiments, the distal end portion 122 of the needle120 can be rotated when the energy source 150 is being actuated. Forexample, in some embodiments, the user can “fan” the distal end portion122 of the needle 120 (i.e., move the distal end portion 122 in adirection not parallel to a longitudinal axis of the needle 120) withinthe skin SK when the energy source is being actuated. Moreover, thedistal end portion 122 of the needle 120 can be moved any suitabledistance when the energy source 150 is being actuated. In someembodiments, for example, the distal end portion 122 of the needle 120can be moved a distance of at least 4 millimeters during actuation ofthe energy source 150.

Returning to the flow chart shown in FIG. 1, in some embodiments, themethod can optionally include regulating a flow rate of the dermalfiller through the distal end portion of the needle when the energysource is being actuated, at 18. In this manner, the user can adjust theamount the dermal filler being injected within and/or beneath the skinto provide the desired cosmetic and/or therapeutic results. In someembodiments, for example, the flow rate of the dermal filler can beregulated to maintain a substantially constant flow rate of the dermalfiller through the distal end portion of the needle when the distal endportion of the needle is moved within and/or beneath the skin. Saidanother way, in some embodiments, the flow rate of the dermal filler canbe regulated to produce a substantially uniform bead of dermal fillerwithin the skin. In some embodiments, for example, the flow rate of thedermal filler can be regulated when the needle is moved within the skinto produce a substantially uniform bead of dermal filler having a volumeof approximately 1 to 2 cubic centimeters and a length of betweenapproximately 4 millimeters and 13 millimeters. In other embodiments,the flow rate of the dermal filler can be regulated when the needle ismoved within the skin to produce a substantially uniform bead of dermalfiller having a volume of less than 1 cubic centimeter and a length ofbetween approximately 4 millimeters and 13 millimeters. For example, insome embodiments, the flow rate of the dermal filler can be regulatedwhen the needle is moved within the skin to produce a substantiallyuniform bead of dermal filler having a volume of approximately 0.1 to0.2 cubic centimeter and a length of between approximately 4 millimetersand 13 millimeters. In yet other embodiments, the flow rate of thedermal filler can be regulated when the needle is moved within the skinto produce a substantially uniform bead of dermal filler having a volumeof greater than 2 cubic centimeter (e.g., a volume of 3, 4, 5, or 10cubic centimeters) and a length of up to 150 millimeters. Such a beadcan be used, for example, to increase the skin volume in the areas ofthe nasal labial fold, the jowls and/or the neck region, and can smooththe appearance of wrinkles in those areas.

The flow rate of the dermal filler can be regulated to produce anysuitable flow rate. For example, in some embodiments, the flow rate ofthe dermal filler can be regulated to a substantially constant flow rateof at least approximately 0.02 cubic centimeters per minute. In otherembodiments, the flow rate of the dermal filler can be regulated to asubstantially constant flow rate of between approximately 0.02 cubiccentimeters per minute and 0.5 cubic centimeters per minute. In yetother embodiments, the flow rate of the dermal filler can be regulatedto a substantially constant flow rate of as much as 3 cubic centimetersper minute. In still other embodiments, the flow rate of the dermalfiller can be regulated to a substantially constant flow rate greaterthan 3 cubic centimeters per minute.

Although the flow rate of the dermal filler through the distal endportion of the needle is described above as being regulated to asubstantially constant value when the needle is moved within the body,in some embodiments, the flow rate of the dermal filler can beselectively varied during the injection process. In this manner, theuser can produce a bead and/or set of beads of dermal filler within theskin having spatially varied volume. Moreover, referring to the flowchart in FIG. 1, in some embodiments, the method 10 can includeoptionally regulating a flow rate of the dermal filler through thedistal end portion of the needle such that the flow rate issubstantially zero at a first time after the needle has been moved andstill remains in the skin, at 20. Said another way, in some embodiments,the method 10 can include optionally stopping the flow of the dermalfiller through the distal end portion of the needle after the needle hasbeen moved within the skin. The distal end portion of the needle canthen be moved while the flow rate of the dermal filler through thedistal end portion of the needle is zero, at 22. The flow rate of thedermal filler through the distal end portion of the needle can then beregulated such that the flow rate is increased greater than zero, at 24.In this manner, the user can produce a discontinuous bead and/or set ofbeads of dermal filler within the skin, as shown in FIG. 5. In someembodiments, for example, the flow rate of the dermal filler through thedistal end portion of the needle can be regulated such that at least onediscrete bead from the set of beads has a volume of approximately 0.1cubic centimeters or less. In other embodiments, the flow rate of thedermal filler through the distal end portion of the needle can beregulated such that at least one discrete bead from the set of beads hasa volume of less than approximately 0.01 cubic centimeters or less. Insome embodiments, the flow rate of the dermal filler through the distalend portion of the needle can be regulated to produce such a set ofdiscontinuous beads in areas of the skin surrounding the eye.

As described in more detail herein, the flow rate of the dermal fillerthrough the distal end portion of the needle can be regulated in anysuitable manner. For example, referring to FIGS. 2-4, in someembodiments, the flow rate of the dermal filler 118 through the distalend portion 122 of the needle 120 can be regulated by selectivelycontrolling the energy from the energy source 150 to the medicalinjector 100. Said another way, in some embodiments, the flow rate ofthe dermal filler 118 through the distal end portion 122 of the needle120 can be regulated by mechanisms outside of the flow path of thedermal filler 118. Moreover, in some embodiments, the flow rate of thedermal filler 118 through the distal end portion 122 of the needle 120can be regulated via the actuator 153. For example, in some embodiments,the user can repeatedly and/or controllably actuate the energy source150 using the actuator 153. Said another way, in some embodiments, theuser can repeatedly toggle the actuator 153 to selectively couple theenergy source 150 to and decouple the energy source 150 from themedicament injector 100. In this manner, for example, the flow rate ofthe dermal filler can be regulated to produce a discontinuous beadand/or set of beads of dermal filler within the skin, as describedabove.

In other embodiments, the flow rate of the dermal filler 118 through thedistal end portion 122 of the needle 120 can be regulated by selectivelyrestricting the flow path of the dermal filler 118 within the medicalinjector 100 and/or the needle 120. For example, in some embodiments,the flow rate of the dermal filler 118 through the distal end portion122 of the needle 120 can be regulated by a valve within the medicamentflow path.

FIGS. 6 and 7 are schematic illustrations of a medical device 200,according to an embodiment configured inject a medicament 218. Themedical device 200 includes a medicament container 210, a needle 220, anenergy source 250 and a regulator 260. The medicament container 210includes a piston 214 movably disposed therein, such that the medicamentcontainer 210 is divided into a first portion 215 and a second portion217. In some embodiments, for example, the piston 214 can be disposedwithin the medicament container 210 such that the first portion 215 ofthe medicament container 210 is fluidically isolated from the secondportion 217 of the medicament container 217.

The first portion 215 of the medicament container 210 is configured tocontain a medicament 218 having a high viscosity (i.e., a medicamenthaving a viscosity of at least 100 Poise). The medicament 218 can be anymedicament suitable for being injected into a body. For example, in someembodiments, the medicament 218 can be a high viscosity dermal filler(e.g., a liquid dermal filler, a paste-like dermal filler, a dermalfiller including both a liquid component and a solid component, or thelike). In some embodiments, the medicament 218 can have a viscosity ofat least 1000 Poise (100 N-sec/m²). In other embodiments, the medicament218 can have a viscosity of at least 10,000 Poise. In yet otherembodiments, the medicament 218 can have a viscosity of at least 100,000Poise.

In some embodiments, the medicament 218 can be a fluid that ischaracterized by a substantially linear shear stress as a function ofthe rate of shear strain applied thereto. Said another way, in someembodiments, the medicament 218 can be a Newtonian fluid having aviscosity that varies substantially only as a function of itstemperature and pressure. In other embodiments, the medicament 218 canbe a fluid that is characterized by a non-linear shear stress as afunction of the rate of shear strain applied thereto. Said another way,in some embodiments, the medicament 218 can be a non-Newtonian fluidhaving a viscosity that varies according other factors, such as, forexample, the magnitude of and/or rate of increase of a force applied tothe medicament 218.

The needle 220 is coupled to the medicament container 210 such that theneedle 220 is in fluid communication with the first portion 215 of themedicament container 210. The needle 220 can be coupled to themedicament container 210 by any suitable mechanism. For example, in someembodiments, the needle 220 can be coupled to the medicament container210 by a Luer fitting that provides a substantially fluid-tight seal(i.e., a seal that that substantially prevents a liquid and/or a gasfrom passing therethrough) between the needle 220 and the medicamentcontainer 210. In some embodiments, the fluid-tight seal can be ahermetic seal (i.e., a seal that substantially prevents a gas frompassing therethrough).

The needle 220 can have any suitable bore size and length. For example,in some embodiments, the needle can have a small bore to reduce patientdiscomfort during a procedure. For example, in some embodiments, theneedle 220 can define a lumen having a nominal inner diameter of lessthan or equal to approximately 0.191 millimeters (i.e., a 27 gaugeneedle). In other embodiments, the needle 220 can define a lumen havinga nominal inner diameter of less than or equal to approximately 0.140millimeters (i.e., a 30 gauge needle). In some embodiments, for example,the needle 220 can define a lumen having a nominal inner diameter ofapproximately 0.114 millimeters (i.e., a 31 gauge needle). In someembodiments, for example, the needle 220 can define a lumen having anominal inner diameter of approximately 0.089 millimeters (i.e., a 32gauge needle). In some embodiments, the needle 220 can have a length ofat least 17 millimeters.

When the piston 214 moves within the medicament container 210, as shownby the arrow DD in FIG. 7, the medicament 218 is conveyed from the firstportion 215 of the medicament container 210. Said another way, a usercan inject the medicament 218 into a body by actuating the medicaldevice 200 to cause the piston 214 to move distally within themedicament container 210. As shown in FIGS. 6 and 7, the energy source250 is operatively coupled to the piston 214 such that the piston 214can be moved non-manually. The energy source 250 can be any suitableform of energy configured produce kinetic energy to move the piston 214within the medicament container 210. The amount of kinetic energyrequired to move the piston 214 within the medicament container 210 isdependent on, among other things, the viscosity of the medicament 218,the desired flow rate of the medicament 218 through the distal endportion 222 of the needle 220, the length of the needle 220 and/or thesize of the lumen defined by the needle 220. In some embodiments, theenergy source 250 can produce kinetic energy sufficient to move thepiston 214 such that a medicament 218 having a viscosity of at least1000 Poise can be injected through the distal end portion 222 of theneedle at a flow rate of at least 0.02 cubic centimeters per minute. Inother embodiments, the energy source 250 can produce kinetic energysufficient to move the piston 214 such that a medicament 218 having aviscosity of at least 1000 Poise can be injected through the distal endportion 222 of the needle at a flow rate of at least 0.5 cubiccentimeters per minute. In yet other embodiments, the energy source 250can produce kinetic energy sufficient to move the piston 214 such that amedicament 218 having a viscosity of at least 10,000 Poise can beinjected through the distal end portion 222 of the needle 220 at a flowrate of at least 0.5 cubic centimeters per minute. In still otherembodiments, the energy source 250 can produce kinetic energy sufficientto move the piston 214 such that a medicament 218 having a viscosity ofat least 10,000 Poise can be injected through the distal end portion 222of the needle 220 at a flow rate of at least 3 cubic centimeters perminute. In still other embodiments, the energy source 250 can producekinetic energy sufficient to move the piston 214 such that a medicament218 having a viscosity of at least 10,000 Poise can be injected throughthe distal end portion 222 of the needle 220 at a flow rate of between 3and 5 cubic centimeters per minute.

Additionally, the pressure of the medicament 218 within the medicamentcontainer 210 during an injection event is related to the kinetic energyapplied to the piston 214, and is therefore also dependent on, amongother things, the viscosity of the medicament 218, the desired flow rateof the medicament 218 through the distal end portion 222 of the needle220, the length of the needle 220 and/or the size of the lumen definedby the needle 220. In certain circumstances, the pressure of themedicament 218 within the medicament container 210 can be modeled by theHagen-Poiseuille law, as indicated below:

P=(8*μ*L*Q)/(Π*R ⁴)   (1)

where P is the pressure of the medicament 218 within the medicamentcontainer, μ is the viscosity of the medicament 218, L is the length ofthe needle 220, Q is the flow rate of the medicament 218 through thedistal end portion 222 of the needle 220, and R is the radius of thelumen defined by the needle 220. Because the pressure required to injecta high viscosity fluid through a small-bore needle is proportional tothe inverse of the radius of the lumen of the needle to the fourthpower, the pressure of the medicament 218 within the medicamentcontainer 210 necessary to achieve the desired flow rate can, at times,be relatively high. In some embodiments, the energy source 250 can beconfigured to move the piston 214 within the medicament container 210such that a pressure of the medicament 218 within the medicamentcontainer 210 is greater than 345 kilopascals (50 p.s.i.). In otherembodiments, the energy source 250 can be configured to move the piston214 within the medicament container 210 such that a pressure of themedicament 218 within the medicament container 210 is greater than 690kilopascals (100 p.s.i.). In still other embodiments, the energy source250 can be configured to move the piston 214 within the medicamentcontainer 210 such that a pressure of the medicament 218 within themedicament container 210 is greater than 1035 kilopascals (150 p.s.i.).In still other embodiments, the energy source 250 can be configured tomove the piston 214 within the medicament container 210 such that apressure of the medicament 218 within the medicament container 210 isgreater than 34.5 Megapascals (5000 p.s.i.).

The regulator 260 is configured to regulate the flow rate of themedicament 218 through the distal end portion 222 of the needle 220. Inthis manner, the user can adjust the flow rate of the medicament 218through the distal end portion 222 of the needle 220. In someembodiments, for example, the regulator 260 can substantially stop theflow of the medicament 218 through the distal end portion 222 of theneedle 220. In this manner, as described above, the user candiscontinuously inject the medicament 218 within the body.

The regulator 260 can be any suitable mechanism for regulating the flowrate of the medicament 218 through the distal end portion 222 of theneedle 220. As described above, in some embodiments, the regulator 260can control the transmission of energy from the energy source 250 to thepiston 214. In other embodiments, the regulator 260 can selectivelyrestrict the flow path of the medicament 218 within the first portion215 of the medicament container 210 and/or the needle 220.

FIGS. 8-10 show a system 300 that employs a pressurized fluid to injecta dermal filler according to an embodiment. The system 300 includes amedicament container 310, a needle (not shown in FIG. 8), a source ofpressurized fluid 351 (see FIGS. 9 and 10), a regulator 360 (see FIGS. 9and 10), and an adapter 330 configured to couple the medicamentcontainer 310 to the source of pressurized fluid 351. The medicamentcontainer 310 is a substantially rigid container having a proximal endportion 311 and a distal end portion 312. The medicament container 310includes a piston 314 movably disposed therein such that the medicamentcontainer 310 is divided into a first portion 315 and a second portion317. The first portion 315 of the medicament container 310 is configuredto contain a dermal filler 318 having a high viscosity. The medicament318 can be any medicament suitable for being injected into a body, asdescribed herein.

A coupler 325 is disposed at the distal end portion 312 of themedicament container 310. The coupler 325 is configured to removablycouple the needle (not shown in FIG. 8) to the distal end portion 312 ofthe medicament container 310 such that the needle is in fluidcommunication with the first portion 315 of the medicament container310. The coupler 325 can include any suitable coupling mechanismconfigured to produce a substantially fluid-tight coupling between theneedle and the medicament container 310. For example, in someembodiments, the coupler 325 can be a Luer lock fitting that threadedlyengages a hub of the needle and maintains the hub in position about aprotrusion (not shown in FIG. 8) at the distal end portion 312 of themedicament container 310. In such an arrangement, the protrusion and theneedle hub can have mating tapered surfaces such that a substantiallyfluid-tight interface is produced when the needle hub is coupled to themedicament container 310 by the coupler 325.

The adapter 330, which is configured to couple the medicament container310 to the source of pressurized fluid 351, includes a tube 342 and acoupler 343. The tube 342 includes a proximal end portion 347 and adistal end portion 348. The distal end portion 348 of the tube 342 isdisposed about a barbed fitting 313 of the medicament container 310 tocouple the medicament container 310 to the adapter 330. The distal endportion 348 of the tube 342 can be secured about the barbed fitting 313,for example, by the elastic properties of the tube 342 (i.e., aninterference fit between the tube 342 and the barbed fitting 313), anexternal clamp (not shown), an adhesive, and/or the like. The coupler343 is coupled to the proximal end portion 347 of the tube 342, and isconfigured to couple the tube 342 to the source of pressurized fluid351, as described in more detail below.

As shown in FIGS. 9 and 10, the source of pressurized fluid 351 and theregulator 360 are contained within the housing 354. In this manner, theflow rate and/or the pressure of the pressurized fluid delivered fromthe source of pressurized fluid 351 to the medicament container 310 canbe regulated and/or actuated by the integrated assembly within thehousing 354. The source of pressurized fluid 351 can include anysuitable fluid (e.g., a gas or a liquid) configured to produce apressure when conveyed to the second portion 317 of the medicamentcontainer 310, as described in more detail below. In some embodiments,for example, the source of pressurized fluid 351 can be a compressed CO₂cartridge configured to be threadedly coupled to the housing 354. Inother embodiments, the source of pressurized fluid 351 can include areservoir, an accumulator and/or an adapter configured to receive apressurized gas from an external source (i.e., a facility gas supplysystem).

The housing 354 includes an actuator 353, a coupler fitting 355 and aregulator knob 361. The coupler fitting 355 is configured to receive thecoupler 343 of the adapter 330 such that the proximal end portion 347 ofthe tube 342 can be removably coupled to the housing 354. In thismanner, the medicament container 310 can be coupled to the source ofpressurized fluid 351. Said another way, in this manner, the piston 314can be operatively coupled to the source of pressurized fluid 351. Saidyet another way, in this manner, the second portion 317 of themedicament container 310 can be placed in a fluidic circuit with thesource of pressurized fluid 351 such that the second portion 317 of themedicament container 310 can be selectively placed in fluidcommunication with the source of pressurized fluid 351.

The actuator 353, which can be, for example, a push button actuator, isconfigured to selectively place the second portion 317 of the medicamentcontainer 310 in fluid communication with the source of pressurizedfluid 351. Similarly stated, the actuator 353 can selectively limit theflow rate and/or the pressure of the pressurized fluid delivered fromthe source of pressurized fluid 351 to the second portion 317 of themedicament container 310. In this manner, the user can actuate theactuator 353 to initiate the non-manual injection of the dermal filler318 from the medicament container 310 through the needle (not shown inFIG. 8). As described above, because the dermal filler 318 is conveyedfrom the medicament container 310 non-manually, the user is not burdenedwith producing the energy and/or force necessary to cause the dermalfiller 318 to be conveyed at the desired flow rate. This arrangement canresult in a repeatable, continuous and/or controlled injection of thedermal filler 318.

Although the actuator 353 is shown as being actuated by a push buttondisposed on the housing 354, in other embodiments, the actuator 353 canbe actuated via a foot switch (not shown in FIGS. 9 and 10) coupled tothe housing 354. In such embodiments, the user can initiate theinjection of the dermal filler 318 in a “hands free” manner, therebyallowing the user to use their hands to control the placement and/or themovement of the needle within the body. In such embodiments, the footswitch can be any suitable switch configured to cause the actuator 353to selectively place the second portion 317 of the medicament container310 in fluid communication with the source of pressurized fluid 351. Thefoot switch can be, for example, an electronic switch, a pneumaticswitch or the like. In some embodiments, for example, the foot switchcan be wirelessly coupled to the actuator 353.

The regulator knob 361 can be used to adjust the regulator 360 toselectively regulate the flow rate and/or the pressure of thepressurized fluid delivered from the source of pressurized fluid 351 tothe second portion 317 of the medicament container 310 when the actuator353 is actuated. In this manner, the flow rate of the dermal filler 318from the medicament container 310 can be regulated. This arrangementallows the flow rate of the dermal filler 318 to be regulated withoutaffecting the flow path of the dermal filler 318 and/or without anyportion of the regulator 360 contacting the dermal filler 318.

The regulator 360 can be any suitable mechanism configured to regulatethe flow rate and/or the pressure of the pressurized fluid from thesource of pressurized fluid 351. For example, in some embodiments, theregulator 360 include components from an EFD® dispensing system, suchas, for example, the EFD® 2400 pneumatic dispenser or the EFD® 2800hydraulic controller manufactured by EFD, Inc. (a Nordson Company).

In some embodiments, the distal end portion 348 of the tube 342 isremovably coupled to the medicament container 310. In this manner, a kitaccording to an embodiment can include the adapter 330 and one or moremedicament containers 310 pre-filled with the dermal filler 318. Forexample, in some embodiments, a kit can include multiple medicamentcontainers 310 pre-filled with different volumes of the dermal filler318. In this manner, the user can select from among the pre-filledmedicament containers 310 based on the amount of dermal filler 318 to beinjected (e.g., the amount of dermal filler necessary for the desiredcosmetic and/or therapeutic result). For example, in some embodiments, akit can include pre-filled medicament containers 310 containingapproximately 1 cubic centimeter, 2 cubic centimeters, 3 cubiccentimeters, 5 cubic centimeters and/or 10 cubic centimeters of dermalfiller 318. In other embodiments, a kit can include pre-filledmedicament containers 310 containing greater than 10 cubic centimetersof dermal filler 318.

Such pre-filled medicament containers can accommodate increased volumeof the dermal filler 318 by having an increased length and/or anincreased inner diameter. Because the dermal filler 318 is injectednon-manually, as described above, the length and/or the inner diameterof the medicament container 310 can be varied without regard to thephysical limitations associated with actuating the medicament containermanually. More particularly, because the dermal filler 318 is injectednon-manually, the length and/or the inner diameter of the medicamentcontainer 310 can be varied independently from the distance throughwhich an average user can manually depress a plunger and/or the forcethat an average user can apply when manually depressing a plunger.

In contrast, some known medical injectors are limited in the volume ofdermal filler that can be contained therein because of the physicalconstraints imposed by manually actuating the medical injector. Moreparticularly, some known medical injectors are configured contain amaximum of approximately 1 cubic centimeter of dermal filler. In suchknown manually-actuated injectors, the medicament pressure duringinjection is inversely proportional to the square of the inner diameter.Thus, increasing the size of the inner diameter to allow a greatervolume of dermal filler to be contained within the medical injector canresult in an increase in the force required to generate the desiredmedicament pressure. Accordingly, because the force that can be appliedmanually by a user is limited, increasing the size of the inner diameteris often not desirable. Similarly, the length of travel of the pistonwithin the medicament container (i.e., the stroke of the injector) canbe increased to allow a greater volume of dermal filler to be containedwithin the medical injector. However, the distance through which thepiston can be moved is also limited based on the size of the user'shand.

Although the adapter 330 is shown and described above as being coupledto the medicament container 310 via the barbed fitting 313, in otherembodiments, an adapter can be coupled to a medicament container havinga flange. In this manner, the adapter can be configured to receive aflanged syringe. One such embodiment is shown in FIG. 11, which shows aportion of a system 400 that employs a pressurized fluid to inject adermal filler according to an embodiment. The system 400 includes amedicament container 410, a needle (not shown in FIG. 11), a source ofpressurized fluid (not shown in FIG. 11), and an adapter 430 configuredto couple the medicament container 410 to the source of pressurizedfluid. The source of pressurized fluid can be similar to the source ofpressurized fluid 351 shown and described above. Additionally, thesystem 400 can include a regulator similar to regulator 360 shown anddescribed above, and an actuator similar to the actuator 353 shown anddescribed above. Accordingly, only the medicament container 410 and theadapter 430 are discussed in detail below.

The medicament container 410, which can be, for example, acommercially-available syringe, has a proximal end portion 411 and adistal end portion 412. The medicament container 410 includes a piston414 movably disposed therein such that the medicament container 410 isdivided into a first portion 415 and a second portion 417. The firstportion 415 of the medicament container 410 is configured to contain adermal filler 418 having a high viscosity. The medicament 418 can be anymedicament suitable for being injected into a body, as described herein.A coupler 425 is disposed at the distal end portion 412 of themedicament container 410. As described above, the coupler 425 isconfigured to removably couple the needle (not shown in FIG. 11) to thedistal end portion 412 of the medicament container 410.

The adapter 430, which is configured to couple the medicament container410 to the source of pressurized fluid, includes a hand piece 449, atube 442 and a coupler 443. The hand piece 449 includes a proximal endportion 431, a distal end portion 432, and an outer surface that can becontoured to assist the user in gripping and/or manipulating the handpiece 449. The distal end portion 432 of the hand piece 449 includes acoupler 433 configured to removably couple the hand piece 449 to themedicament container 410. More particularly, the coupler 433 isconfigured to couple the hand piece 449 to a standard,commercially-available syringe. In this manner, the adapter 430 can beused on a variety of different medicament containers 410.

The coupler 433 includes a protrusion 434, a sealing member 435, and twocoupling members 436. The protrusion 434 is configured to be disposedwithin the second portion 417 of the medicament container 410 when thecoupler 433 is coupled to the medicament container 410. The sealingmember 435 is disposed about the protrusion 434 and forms asubstantially fluid-tight seal between the protrusion 434 and the innersurface of the medicament container 410 when the coupler 433 is coupledto the medicament container 410. In this manner, the pressurized fluidconveyed from the source of pressurized fluid to the second portion 417of the medicament container 410 is maintained within the second portion417 of the medicament container 410 (i.e., the pressurized fluid doesnot leak out of the second portion 417 of the medicament container 410).The sealing member 435 can be, for example, an o-ring, and can beconstructed from any suitable material that is compatible with themedicament 418 and/or the pressurized fluid from the source ofpressurized fluid.

The coupling members 436 are disposed approximately equidistancecircumferentially about the coupler 433. Said another way, the couplingmembers 436 are disposed approximately 180 degrees apart. In this mannerthe coupling members 436 engage the flange 413 of the medicamentcontainer 410 at two distinct circumferential locations when the coupler433 is coupled to the medicament container 410. As shown in FIG. 11,each coupling member 436 includes a protrusion 437 that defines achannel within which the flange 413 of the medicament container 410 isreceived when the coupler 433 is coupled to the medicament container410. More particularly, each coupling members 436 is configured to bendoutwardly, as shown by the arrow EE, when pressed against the flange 413to allow the flange 413 be disposed within the channel. When the flange413 is disposed within the channel, the coupling members move back totheir respective relaxed positions such that the flange 413 and thecoupling members 436 cooperatively limit the axial movement of themedicament container 410 relative to the hand piece 449.

The tube 442 includes a proximal end portion 447 and a distal endportion 448. The distal end portion 448 of the tube 442 is coupled tothe barbed fitting at the proximal end portion 431 of the hand piece449. The distal end portion 448 of the tube 442 can be secured about thebarbed fitting, for example, by the elastic properties of the tube 442(i.e., an interference fit between the tube 442 and the barbed fitting),an external clamp (not shown), an adhesive, and/or the like. The coupler443 is coupled to the proximal end portion 447 of the tube 442, and isconfigured to couple the tube 442 to the source of pressurized fluid, asdescribed above.

Although the adapter 430 is shown as being configured to convey apressurized fluid into the second portion 417 of the medicamentcontainer 410, in other embodiments, an adapter and/or a hand piece canbe configured to indirectly couple a medicament container and/or apiston to a source of pressurized fluid. For example, in someembodiments, an adapter and/or a hand piece can be configured to convertand/or amplify the pressure produced by the source of pressurized fluidto move a piston with sufficient force to generate the desiredmedicament flow rates and/or medicament pressure. One such embodiment isshown in FIG. 12, which shows a portion of a system 500 that employs apressurized fluid to inject a dermal filler according to an embodiment.The system 500 includes a medicament container 510, a needle 520, asource of pressurized fluid (not shown in FIG. 12), and an adapter 530configured to couple the medicament container 510 to the source ofpressurized fluid. The source of pressurized fluid can be similar to thesource of pressurized fluid 351 shown and described above. Additionally,the system 500 can include a regulator similar to regulator 360 shownand described above, and an actuator similar to the actuator 353 shownand described above. Accordingly, only the adapter 530 and themedicament container 510 are discussed below.

The medicament container 510 has a proximal end portion 511 and a distalend portion 512. The distal end portion 512 is coupled to the needle520, as discussed above. The proximal end portion 511 is coupled to theadapter 530, as discussed below. The medicament container 510 includes afirst piston 514 movably disposed therein. The first piston 514 has adiameter d1.

The adapter 530 includes a hand piece 549, a tube 542 and a coupler 543.The tube 542 includes a proximal end portion 547 and a distal endportion 548. The distal end portion 548 of the tube 542 is coupled tothe proximal end portion 531 of the hand piece 549. The coupler 543 iscoupled to the proximal end portion 547 of the tube 542, and isconfigured to couple the tube 542 to the source of pressurized fluid, asdescribed above. In this manner, a pressurized fluid can be conveyedfrom the source of pressurized fluid into the hand piece 549, asdescribed below.

The hand piece 549 includes a proximal end portion 531 and a distal endportion 532. The distal end portion 532 of the hand piece 549 includes acoupler 533 configured to removably couple the hand piece 549 to themedicament container 510. As described above, the coupler 533 includestwo coupling members 536 that are disposed approximately equidistancecircumferentially about the coupler 533. Said another way, the couplingmembers 536 are disposed approximately 180 degrees apart. In this mannerthe coupling members 536 engage the flange 513 of the medicamentcontainer 510 at two distinct circumferential locations when the coupler533 is coupled to the medicament container 510.

The hand piece 549 defines a lumen 544, within which a second piston546, having a diameter d2, and a push rod 545 are movably disposed. Whenthe hand piece 549 is coupled to the medicament container 510 by thecoupler 533, the second piston 546 is coupled to the first piston 514 bythe push rod 545. Accordingly, when the hand piece 549 is coupled to themedicament container 510 by the coupler 533, a force acting on thesecond piston 546 is transferred directly to the first piston 514. Inthis manner, when a pressurized fluid from the source of pressurizedfluid is conveyed into the lumen 544, the force exerted by thepressurized fluid on the second piston 546 is transferred to the firstpiston 514.

The corresponding pressure of the dermal filler in the medicamentcontainer 510 (P1) and the pressure of the pressurized fluid in thelumen 544 of the hand piece 549 (P2) are defined by equations (2) and(3) below:

P1=F/A1   (2)

P2=F/A2,   (3)

where F is the force exerted by the pressurized fluid on the secondpiston 546, and A1 and A2 are the surface area of the first piston 514and the second piston 546, respectively. Because the force F acting onthe first piston 514 is the same as the force F acting on the secondpiston 546 under steady-state conditions, equations (2) and (3) can berearranged to define the relationship between the pressure P2 of thepressurized fluid and the pressure P1 of the dermal filler:

P1=(A2/A1)*P2.   (4)

As illustrated by equation (4), the delivery pressure P1 of the dermalfiller in the medicament container can be controlled by controlling thepressure P2 of the pressurized fluid in the hand piece 549 and/or byadjusting the area ratio (also referred to as the amplification factor)of the second piston 546 and the first piston 514. In this manner, thehand piece 549 can amplify the pressure of the pressurized fluid.

The hand piece 549 can be configured to produce any desired amount ofpressure amplification. For example, in some embodiments, the firstpiston 514 can have a diameter d1 (i.e., the inner diameter of themedicament container 510) of approximately 5 mm (0.20 inches), and thesecond piston 546 can have a diameter d2 of approximately 22 mm (0.88inches). In such embodiments, the amplification factor is approximately19.3. Accordingly, a pressure within the hand piece 549 of approximately890 kPa (130 p.s.i.) will result in a pressure within the medicamentcontainer of approximately 17.2 MPa (2500 p.s.i.).

In other embodiments, it is desirable for the first piston 514 to have adiameter greater than 5 mm. For example, in some embodiments, themedicament container 510 is configured to contain approximately 2 cubiccentimeters of dermal filler, and therefore has an inner diameter ofapproximately 7 mm (0.28 inches). The second piston 546 can have adiameter d2 of approximately 22 mm (0.88 inches), resulting in anamplification factor of approximately 9.9. Accordingly, a pressurewithin the hand piece 549 of approximately 690 kPa (100 p.s.i.) willresult in a pressure within the medicament container of approximately6.9 MPa (1000 p.s.i.).

In some embodiments, it is desirable for the second piston 546 to have adiameter less than 22 mm, for example, to provide improvedmaneuverability during use. For example, in some embodiments, themedicament container 510 is configured to contain approximately 2 cubiccentimeters of dermal filler, and has an inner diameter of approximately7 mm (0.28 inches). The second piston 546 can have a diameter d2 ofapproximately 15.7 mm (0.62 inches), resulting in an amplificationfactor of approximately 5. Accordingly, a pressure within the hand piece549 of approximately 690 kPa (100 p.s.i.) will result in a pressurewithin the medicament container of approximately 3.5 MPa (500 p.s.i.).

Although the adapter 530 is shown and described above as being coupledto the medicament container 510 by two coupling members 536 configuredto engage the flange 513 of the medicament container 510, in otherembodiments, an adapter can be coupled to a medicament container in anysuitable manner. For example, in some embodiments, an adapter can becoupled to a medicament container by three, four, or more couplingmembers. In this manner, the medicament container can be securelyfastened to the adapter to withstand the high pressures (and thereforethe resulting forces) that can be applied during use. In otherembodiments, an adapter can be coupled to a medicament container by anut configured to engage a flange of the medicament containersubstantially around the entire circumference of the flange. Forexample, FIG. 13 shows a portion of a system 600 that employs apressurized fluid to inject a dermal filler according to an embodiment.The system 600 includes a medicament container 610, a needle 620, asource of pressurized fluid (not shown in FIG. 13), and an adapter 630configured to couple the medicament container 610 to the source ofpressurized fluid. The system 600 is similar in many respects to thesystem 500 described above, and is therefore not described in detailbelow. The system 600 differs, however, in that the adapter 630 iscoupled to the medicament container 610 by a coupling nut 639.

The coupling nut 639 is disposed about the proximal end portion 611 ofthe medicament container 610 such that a shoulder (not shown) of thecoupling nut 639 engages the flange (not shown) of the medicamentcontainer 610. The coupling nut 639 is configured to be threadedlycoupled to the distal end portion 632 of the hand piece 649. In thismanner, when the coupling nut 639 is tightened on to the hand piece 649,the shoulder of the coupling nut 639 exerts a coupling force around thecircumference of the flange of the medicament container 610.

Although the regulator 360 is shown and described above as controllingflow rate of dermal filler by regulating the flow rate and/or thepressure of the pressurized fluid delivered from the source ofpressurized fluid 351 to the medicament container 310, in otherembodiments, a regulator can regulate the flow rate of dermal filler byobstructing and/or modifying a flow path of the dermal filler. Similarlystated, although the regulator 360 is shown and described above as beingdisposed outside of the flow path of the dermal filler, in otherembodiments, a regulator can have at least a portion disposed within theflow path of the dermal filler. For example, FIGS. 14-17 show a system600 that includes a self-contained source of pressurized gas to inject adermal filler according to an embodiment.

The system 700 includes a medicament container 710, a needle 720, asource of pressurized fluid 750, and an adapter 730 configured to couplethe medicament container 710 to the source of pressurized fluid. Themedicament container 710 has a proximal end portion 711 and a distal endportion 712. The medicament container 710 includes a first piston 714movably disposed therein. The first piston 714 has a diameter d1. Themedicament container 710 is configured to contain a dermal filler havinga high viscosity. The regulator 760 is disposed at the distal endportion 712 of the medicament container 710. As described in more detailbelow, a coupler 725 is attached to the regulator and is configured toremovably couple the needle 720 to the regulator, and thus to the distalend portion 712 of the medicament container 710. The coupler 725 can beany suitable coupler, as described above. The distal end portion 712 ofthe medicament container 710 includes a flange 713 that can be coupledto the adapter 730, as described below.

The adapter 730 includes a proximal end portion 731 and a distal endportion 732. The distal end portion 732 of the adapter 730 includes acoupler 733 configured to removably couple the adapter 730 to themedicament container 710. As described above, the coupler 733 includestwo coupling members 736 that are disposed approximately equidistancecircumferentially about the coupler 733. Said another way, the couplingmembers 736 are disposed approximately 180 degrees apart. In this mannerthe coupling members 736 engage the flange 713 of the medicamentcontainer 710 at two distinct circumferential locations when the coupler733 is coupled to the medicament container 710.

The adapter 730 defines a lumen 744, within which a second piston 746,having a diameter d2, and a push rod 745 are movably disposed. When theadapter 730 is coupled to the medicament container 710 by the coupler733, the second piston 746 is coupled to the first piston 714 by thepush rod 745. Accordingly, when the adapter 730 is coupled to themedicament container 710 by the coupler 733, a force acting on thesecond piston 746 is transferred directly to the first piston 714. Inthis manner, when a pressurized fluid from the source of pressurizedfluid 750 is conveyed into the lumen 744, the force exerted by thepressurized fluid on the second piston 746 is transferred to the firstpiston 714. As shown in FIG. 14, the diameter d2 of the second piston746 is greater than the diameter d1 of the first piston 714. In thismanner, as described above, the pressure within the medicament container710 can be greater than the pressure supplied by the source ofpressurized fluid 750. Said another way, in this manner, the adapter 730is configured to amplify the pressure of the pressurized fluid from thesource of pressurized fluid 750. In some embodiments, for example,diameter dl of the first piston 714 can be approximately 7 mm (0.28inches) and the diameter d2 of the second piston 746 can beapproximately 12.7 mm (0.5 inches). With such an arrangement, when thepressure provided by the source of pressurized fluid 750 isapproximately 534 kPa (76 p.s.i.), the pressure of the dermal fillerwithin the medicament container 710 is approximately 1.7 MPa (250p.s.i.).

The outer surface of the adapter 730 defines an opening 727 in fluidcommunication with the lumen 744. The opening 727 is positioned towardsa distal end portion 732 of the adapter 730, and is configured to allowfluid within the lumen 744 distally of the second piston 746 to evacuatefrom the adapter 730 when the second piston 746 moves distally withinthe adapter 730. In some embodiments, the opening 727 can include amembrane configured to allow fluids to move through the opening in onlyone direction. In other embodiments, the opening 727 can be configuredto allow fluids to flow freely therethrough in any direction.

The source of pressurized fluid 750 is movably coupled to the proximalend portion 731 of the adapter 730. More particularly, the source ofpressurized fluid 750 can be actuated by moving the source ofpressurized fluid 750 relative to the adapter 730. In this manner, avalve (not shown in FIG. 14) can be opened thereby releasing pressurizedfluid from the source of pressurized fluid 750 into the lumen 744 of theadapter 730. In some embodiments, for example, a release valve (notshown in FIG. 14) can be actuated when the source of pressurized fluid750 is moved relative to the adapter 730, thereby releasing apressurized fluid into the lumen 744 of the adapter. The source ofpressurized fluid 750 can be any suitable source of pressurized fluid,including those described in U.S. Provisional Application Ser. No.61/016,223, entitled “Self-Contained Pressurized Injection Device,”filed Dec. 21, 2007, which is incorporated herein by reference in itsentirety.

As shown in FIGS. 15-17, the regulator 760 includes a regulator body761, a valve member 770, a valve actuator 780, and a valve seat 790. Thevalve actuator 780 includes a lever 781 and two elongated members 782.Each of the elongated members 782 includes a protrusion 783, which canbe disposed within the regulator body 761 (see e.g., FIG. 17). In thismanner, when lever 781 of the valve actuator 780 is moved, the valveactuator 780 can pivot about the protrusions 783.

The regulator body 761 includes a proximal end portion 762 and a distalend portion 763, and defines a lumen 764 therethrough. The side wall ofthe regulator body 761 defines openings 765 within which a portion ofthe actuator 780 can be disposed, as described in more detail herein.The distal end portion 763 of the regulator body 761 includes a stem766, a portion of which is disposed within the hub 724 of the needle720. As described above, the coupler 725 is attached to the stem 766,and is configured to removably couple the needle 720 to the regulator760. The proximal end portion 762 of the regulator body 761 is disposedabout and coupled to the distal end portion 712 of the medicamentcontainer 710. The proximal end portion 762 of the regulator body 761can be coupled to the distal end portion 712 of the medicament container710 by any suitable means, such as, for example, an adhesive, a crimpedfit, an external clamp or the like.

As shown in FIG. 17, a mounting ring 795 is disposed between theproximal end portion 762 of the regulator body 761 and the distal endportion 712 of the medicament container 710 to provide a substantiallyfluid-tight seal between the regulator body 761 and the medicamentcontainer 710. Moreover, the valve seat 790 is coupled to the mountingring 795 such that a seat surface 792 is disposed within the medicamentcontainer 710 facing in a proximal direction. In this manner, themounting ring 795 can position the valve seat 790 relative to theregulator body 761 and/or the valve member 770.

The valve member 770 includes a proximal end portion 771 and a distalend portion 772, and defines a lumen 777. The distal end portion 772 ofthe valve member 770 includes a shoulder 779, a seal 774, and defines anactuation groove 775. As shown in FIG. 17, the seal 774 is configured toengage an inner surface of the regulator body 761 to form asubstantially fluid-tight seal between the valve member 770 and theregulator body 761. The actuation groove 775 is configured to receive aportion of each elongated member 782 of the valve actuator 780. In thismanner, as described in more detail herein, movement of the actuator 780can cause the valve member 770 to move longitudinally within theregulator body 761. The proximal end portion 771 of the valve member 770includes a head 778 and defines openings 776. The openings 776 extendthrough the side wall of the valve member 770 and are in fluidcommunication with the lumen 777 of the valve member 770.

The valve member 770 is movably disposed within the lumen 764 of thevalve body 761 between a first position (e.g., a closed position, asshown in FIG. 17), a second position (e.g., a fully opened position, notshown in FIGS. 14-17), and any number of positions therebetween. In thismanner, the regulator 760 can regulate the flow rate of dermal fillerfrom the medicament container 710 through the needle 720. When the valvemember 770 is in the first position, the head 778 of the valve member770 is disposed against the seat surface 792 of the valve seat 790 toform a substantially fluid-tight seal, as shown in FIG. 17. Accordingly,when the valve member 770 is in the first position, the dermal fillercannot flow from the medicament container 710 through the needle 720.Said another way, when the valve member 770 is in the first position,the flow rate of the dermal filler from the medicament container 710 issubstantially zero. Moreover, because the pressure within the medicamentcontainer 710 produces a force on the head 778 in a distal direction,the pressure within the medicament container tends to maintain the valvemember 770 in the first position. Additionally, as shown in FIG. 17,when the valve member 770 is in the first position, the shoulder 779 ofthe valve member 770 is disposed against a distal portion of the valveseat 790. In this manner, the valve member 770 is maintained in thefirst position by the force of the valve seat 790 on the shoulder 779.

To move the valve member 770 from the first position to the secondposition, the user can move the lever 781 of the valve actuator 780inward, as shown by the arrow FF in FIG. 17. As described above, theinward movement of the lever 781 causes the valve actuator 780 to pivotabout the protrusions 783. In this manner, the elongated members 782 ofthe valve actuator 780 move proximally. A portion of each of theelongate members 782 is disposed within the actuation groove 775 of thevalve member 770. Accordingly, proximal movement of the elongatedmembers 782 causes the valve member 770 to move proximally, as shown bythe arrow GG in FIG. 17. The proximal movement of the valve member 770causes the head 778 to be spaced apart from the seat surface 792,thereby allowing flow of the dermal filler through the openings 776 andinto the lumen 777 of the valve member 770. Said another way, theproximal movement of the valve member 770 causes the head 778 to bespaced apart from the seat surface 792, thereby defining a medicamentflow path (as shown by the dashed line in FIG. 17).

Moreover, when the valve member 770 is moved proximally, the shoulder779 exerts a force on the distal portion of the valve seat 790, therebycausing the distal portion of the valve seat 790 to deform. In thismanner, the distal portion valve seat 790 acts as a biasing member tourge the valve member 770 towards the first position.

The medicaments and/or dermal fillers described above can be anymaterial suitable for augmenting soft tissue. In some embodiments, amedicament and/or dermal filler can include a pain reliever, such as,for example, lidocaine. In other embodiments, a medicament and/or dermalfiller can include a colorant and/or a marker. For example, in someembodiments a medicament and/or dermal filler can include a radio-opaquemarker. In other embodiments, a medicament and/or dermal filler caninclude a tattoo ink.

In some embodiments, a dermal filler can include, for example, a sidechain crystalline (SCC) polymer of the type disclosed in InternationalPatent Application No. PCT/US2007/023226, entitled “Compositions,Devices and Methods for Modifying Soft Tissue,” which is incorporatedherein by reference in its entirety. In other embodiments, a dermalfiller can include hyaluronic acid. In yet other embodiments, a dermalfiller can include polyacrylamide, collagen (either human and/orbovine), polymethylmethacrylate, silicone, calcium hydroxylapatite(CaHA), hydrophilic polyacrylamid gel (PAAG), and/or poly-L-lactic acidhydrogel (PLLA).

In some embodiments, a dermal filler can include any of the followingcommercially-available dermal fillers: Puragen™ and its derivatives,produced by Mentor Corporation, Belotero® and its derivatives, producedby Merz Pharmaceuticals, BIO-ALCAMID™ and its derivatives, produced byPolymekon S.R.L., Outline® and its derivatives, produced by ProCytech,HylaNew® and its derivatives, produced by Prollenium MedicalTechnologies, Inc., Restylane® and its derivatives, produced by Q-Med orMedicis Pharmaceutical Corporation, Reviderm USA and its derivatives,produced by Rofil Medical International N.V., Teosyal® and itsderivatives, produced by Teoxane Laboratories, Fascian® and itsderivatives, produced by Fascia Biosystems, LLC, FG-5017 and itsderivatives, produced by Fibrogen, Inc., Amazingel and its derivatives,produced by FuHua High Molecular Matter Company, Ltd., Laresse® DermalFiller and its derivatives, produced by FzioMed, Inc., Zyderm® and itsderivatives, produced by Inamed Corporation, Isolagen® and itsderivatives, produced by Isolagen, Inc., MacDermol® and its derivatives,produced by Laboratories ORGéV, Juvéderm™ and its derivatives, producedby L.E.A. Derm, Hyaluderm® and its derivatives, produced by LCAPharmaceutical, Silikon® 1000 and its derivatives, produced by Alcon,Inc., Esthèlis and its derivatives, produced by Antesis® S.A., Artefill®and its derivatives, produced by Artes Medical, Inc., Radiesse® and itsderivatives, produced by BioForm Medical, Inc., Matridex® and itsderivatives, produced by BioPolymer GmbH & Co. KG, Evolence® and itsderivatives, produced by ColBar LifeScience Ltd., Aquamid® and itsderivatives, produced by Contura International A/S, SurgiDerm® and itsderivatives, produced by Labortoire Corneal® Development, Rhegecoll andits derivatives, produced by Dermabiol Institute of Kuhra Vital GmbH,DermaLive® and its derivatives, produced by Derma Tech, and/or Sculptra™and its derivatives, produced by Dermik® Laboratories.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

Although the energy sources are shown and described above as including apressurized fluid, in other embodiments, an energy source can includeany suitable form of stored energy and/or a mechanism configured toconvert energy from one form to another. For example, in someembodiments an energy source can include a source of stored electricalenergy (e.g., a battery), a source of chemical energy (e.g., productsthat react to produce energy), and/or a source of mechanical energy(e.g., a spring). In other embodiments, an energy source can include amechanism configured to convert electrical potential energy to a kineticenergy. For example, in some embodiments, an energy source can includean electric motor (e.g., a stepper motor) configured to receiveelectrical energy (from a battery or from an AC power source) andconvert the electrical energy into a kinetic energy to move a piston.

Although the medicament containers are shown and described above asincluding a piston, in other embodiments, a medicament container can bedevoid of a piston. For example, in some embodiments, a fluid poweredinjection system can include a medicament container devoid of a piston,and include a source of pressurized fluid. The dermal filler containedwithin the medicament container can have a high viscosity such that itwill not readily mix with the pressurized fluid. Accordingly, to actuatethe injector, the pressurized fluid is conveyed into the medicamentcontainer and in direct contact with the dermal filler to be injected,thereby moving the dermal filler within the medicament container.

Although the coupling members 436 are shown and described as beingconfigured to bend outwardly when the coupler 433 is being coupled tothe medicament container 410, in other embodiments, the coupling members436 can be substantially rigid. For example, in some embodiments, theflange 413 of the medicament container 410 does not extendcircumferentially around the medicament container 410, but rather theremay be two flanges positioned on opposite sides of the medicamentcontainer 410. In such embodiments, the medicament container 410 can berotated relative to the hand piece 449 until the flanges are out ofalignment with the coupling members 436. The hand piece 449 can then bedisposed about the medicament container 410. The medicament container410 can then be rotated relative to the hand piece 449 until the flangesare aligned with the coupling members 436, thereby securing themedicament container within the hand piece 449.

In some embodiments, for example, an apparatus includes a medicamentcontainer, a needle, an energy source, and a regulator. The medicamentcontainer has a piston movably disposed therein such that the medicamentcontainer is divided into a first portion and a second portion. Thefirst portion of the medicament container is configured to contain amedicament, such as, for example a dermal filler. The needle is coupledto the medicament container such that the needle is in fluidcommunication with the first portion of the medicament container. Theenergy source is operatively coupled to the piston and is configured toproduce a kinetic energy to move the piston within the medicamentcontainer such that the medicament having a viscosity of at least 1000Poise (100 N-sec/m²) can be conveyed from the first portion of themedicament container through a distal end of the needle at a flow rateof at least 0.02 cubic centimeters per minute. The regulator isconfigured to regulate the flow rate of the medicament through thedistal end of the needle.

In some embodiments, for example, an apparatus includes a medicalinjector, a pressurized fluid source, and a regulator. The medicalinjector is configured to contain a dermal filler, and includes aneedle. The needle defines a lumen therethrough having a nominal innerdiameter of less than approximately 0.140 millimeters (i.e., the needleis smaller than 30 gauge), and has a length of at least 17 millimeters.The pressurized fluid source, which can include, for example, a canisterof pressurized fluid, is operatively coupled to the medical injector. Apressurized fluid from the pressurized fluid source has a pressure of atleast 345 kilopascals. The pressurized fluid is configured to actuatethe medical injector such that the dermal filler can be conveyed fromthe medical injector through the lumen of the needle. The regulator isconfigured to regulate the flow rate of the dermal filler through thelumen of the needle.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, in some embodiments, amedical device can include a remotely located source of pressurizedfluid, such as the source of pressurized fluid 351 shown and describedabove, and a regulator coupled to the medicament container, such as theregulator 760 shown and described above.

1. An apparatus, comprising: a medicament container having a pistonmovably disposed therein such that the medicament container is dividedinto a first portion and a second portion, the first portion configuredto contain a medicament; a needle coupled to the medicament containersuch that the needle is in fluid communication with the first portion ofthe medicament container; an energy source operatively coupled to thepiston, the energy source configured to produce a kinetic energy to movethe piston within the medicament container such that the medicamenthaving a viscosity of at least 1000 centipoise can be conveyed from thefirst portion of the medicament container through a distal end of theneedle at a flow rate of at least 0.02 cubic centimeters per minute; anda regulator configured to regulate the flow rate of the medicamentthrough the distal end of the needle.
 2. The apparatus of claim 1,wherein the regulator is configured to substantially stop the flow ofthe medicament and subsequently restart the flow of the medicamentduring an injection event.
 3. The apparatus of claim 1, wherein: theenergy source includes a pressurized fluid, the energy source beingconfigured to convey the pressurized fluid into the second portion ofthe medicament container; and the regulator is configured to regulate atleast one of a pressure of the pressurized fluid or a flow rate of thepressurized fluid into the second portion of the medicament container.4. The apparatus of claim 1, wherein at least a portion of the regulatoris disposed within a medicament delivery path, the medicament deliverypath including at least the first portion of the medicament containerand the needle.
 5. The apparatus of claim 1, wherein the needle definesa lumen therethrough having a nominal inner diameter of less thanapproximately 0.140 millimeters.
 6. The apparatus of claim 1, whereinthe needle has a length of at least 17 millimeters and defines a lumentherethrough having a nominal inner diameter of less than approximately0.191 millimeters.
 7. The apparatus of claim 1, wherein the energystorage member includes a pressurized fluid configured to be conveyed tothe second portion of the medicament container to move the piston withinthe medicament container, a pressure of the pressurized fluid within thesecond portion of the medicament container being greater thanapproximately 690 kilopascals.
 8. The apparatus of claim 1, wherein theenergy storage member includes a pressurized fluid configured to movethe piston within the medicament container such that the medicament canbe conveyed through the distal end of the needle at a flow rate of atleast 0.5 cubic centimeters per minute.
 9. The apparatus of claim 1,wherein the medicament has a viscosity of at least 10,000 centipoise.10. The apparatus of claim 1, wherein the energy storage member includesa pressurized fluid configured to move the piston within the medicamentcontainer, the apparatus further comprising: an adapter configuredoperatively couple the source of pressurized fluid to the piston suchthat a pressure of the medicament within the first portion of themedicament container is greater than a pressure of the pressurized fluidfrom the source of pressurized fluid.
 11. The apparatus of claim 1,wherein the energy storage member includes a pressurized fluidconfigured to move the piston within the medicament container, theapparatus further comprising: an adapter configured couple the source ofpressurized fluid to the medicament container, the adapter including acoupling member configured to engage a flange of the medicamentcontainer in at least two circumferential locations.
 12. An apparatus,comprising: a medical injector configured to contain a dermal filler,the medical injector including a needle defining a lumen therethroughhaving a nominal inner diameter of less than approximately 0.310millimeters, the needle having a length of at least 17 millimeters; apressurized fluid source operatively coupled to the medical injector, apressurized fluid from the pressurized fluid source having a pressure ofat least 345 kilopascals, the pressurized fluid configured to actuatethe medical injector such that the dermal filler can be conveyed fromthe medical injector through the lumen of the needle; and a regulatorconfigured to regulate the flow rate of the dermal filler through thelumen of the needle.
 13. The apparatus of claim 12, wherein theregulator is configured to substantially stop the flow of the dermalfiller and subsequently restart the flow of the dermal filler during aninjection event.
 14. The apparatus of claim 12, wherein the regulator isconfigured to regulate at least one of a pressure of the pressurizedfluid or a flow rate of the pressurized fluid into the medical injector.15. The apparatus of claim 12, wherein at least a portion of theregulator is disposed within a medicament delivery path.
 16. Theapparatus of claim 12, wherein at least a portion of the regulator isconfigured to obstruct a portion of a medicament delivery path.
 17. Theapparatus of claim 12, wherein the pressurized fluid has a pressure ofat least 690 kilopascals.
 18. The apparatus of claim 12, wherein thedermal filler has a viscosity of at least 1000 centipoise.
 19. Theapparatus of claim 12, further comprising: an adapter configured couplethe pressurized fluid source to the medical injector, the adapterincluding a coupling member configured to engage a flange of the medicalinjector in at least two circumferential locations.
 20. The apparatus ofclaim 12, further comprising: an adapter configured couple thepressurized fluid source to the medical injector, the adapter configuredto amplify the pressure of the pressurized fluid such that a pressure ofthe medicament within the medical injector is greater than the pressureof the pressurized fluid from the pressurized fluid source, the adapterincluding a coupling member configured to engage a flange of the medicalinjector, the coupling member configured to substantially surround thecircumference of the flange of the medical injector.